Milk Supplementation and Energy Balance.

Obesity Clinical Trial

Official title:

Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729170
• Other study ID #: 1_Tremblay
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: June 29, 2012
• Start date: October 2006
• Est. completion date: February 2009

Study information

• Verified date: June 2012
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.

Description:

Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of weight by elevating the calcium consumption to reach the recommended level. Milk supplementation could be a good alternative to reach this objective, but its impact on weight loss and on appetite sensations has not been verified. Furthermore, losing weight leads to some negative consequences like a decrease of bone mineral content. Considering the benefits of milk on bone health, a higher intake of this food product during weight loss could represent a healthy strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Low-calcium consumer (less than 800 mg daily)

• BMI between 27 to 42 kg/m2

• Sedentary

• Healthy

Exclusion Criteria:

• In menopause

• Medications that alter the project's objectives

• Smoker

• Dietary supplement consumer

• High alcohol or caffeine consumer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Osteoporosis

Intervention

Dietary Supplement:
• Supplementation of milk (35% more calcium)
The supplement provides 1000 mg of calcium and 250 kcal daily.

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Hôpital Laval	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Dairy Farmers of Canada, National Dairy Council

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition (body weight, fat mass, anthropometric measurements)		Baseline, month 1, and month 6	Yes
Secondary	Bone density (DXA)		Baseline and month 6	Yes
Secondary	Appetite sensations		Baseline, month 1, and month 6	Yes